該職位為博萊科正編
崗位職責:
?Manage and guide the work of the QC Chemical Laboratory Department to ensure all its activities comply with regulatory requirements..
管理和指導 QC 化學室部門的工作,確保化學室的各項活動符合法規要求。
? Familiar with the safety management requirements of the laboratory, assist the QC manager in managing the safety of the entire laboratory.
熟悉實驗室的安全管理要求,協助 QC 經理負責整個實驗室的安全管理工作。
? Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position.
關注和遵守公司要求的質量、環境健康手冊、管理體系和管理政策、目標和該職位的相關的
法規要求。
?Review and approve standard operating procedures, deviation reports, OOS/OOT investigation reports, and other QC related quality documents of QC Chemical laboratory.
審核并批準化學組標準操作規程、偏差報告、OOS/OOT 調查報告和其他 QC 相關質量文件。
? Be responsible for organizing the test of all raw materials, packaging materials, intermediate products, finished products, and process water.
負責組織對原輔料、包裝材料、中間產品、成品、工藝用水的監測。
? Be responsible for the management of instruments, reagents, test solutions, standards, reference materials, and titration solutions.
負責對檢驗用儀器、試劑、試液、標準品、對照品、滴定液的管理。
? Be responsible for stability study of products.
負責產品的穩定性研究及測試。
? Be responsible for validation and calibration activities related to QC.
負責 QC 相關的驗證和計量校驗活動。
? Be responsible for coordinating the implementation of projects related to QC.
負責協調 QC 相關項目的實施。
? Assist in the safety management of QC.
協助實驗室的安全管理工作。
? Be responsible for providing necessary technical data and support to other departments.
負責為其它部門提供必要的技術資料和支持。
? Quality analysis and summary on a regular basis, report to the QC Manager.
定期進行質量分析與總結,向 QC 經理匯報工作。
? Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position.
關注和遵守公司要求的質量、環境健康手冊、管理體系和管理政策、目標和該職位的相關的
法規要求。
Implement the corresponding control measures strictly in accordance with the risk factors identified in the Job Safety Analysis.
按照工作安全分析的風險因素,嚴格執行相應的控制措施。
? Other work assigned by superior.
上級領導交代的其他工作。
任職要求:
? Bachelor’s degree or above in pharmaceutical, chemical or related major.
具有藥學、化學或相關專業本科以上學歷。
? 5 years or above related working experience in laboratory management, familiar with chemical analysis.
5 年或以上相關實驗室管理的工作經驗,熟悉理化分析。
? Familiar with the safety management requirements of the laboratory and related regulations.
熟悉實驗室安全管理要求及相關法規。
? Good spoken and written English skills.
良好的英語口語和讀寫能力。
? Strictly comply with National laws and regulations, EHS and quality management system, abide by the company Code of Conduct, rules and regulations. Ensure that all work behavior conform to company's compliance requirements.
嚴格遵守國家法律法規,遵守 EHS 和質量管理體系規定,遵守公司員工行為準則和各項規章
制度,確保所有的工作行為符合公司的合規要求。